Many patients who already harbor drug-resistant HIV require interruption of HAART due to poor compliance, poor quality of life, toxicity or development of resistance. In these patients interruption of HAART has a negative impact on patient immune status due to the reemergence of wild-type virus which is in general more pathogenic than HIV isolates containing resistance mutations. There is a need for "bridging" antiretroviral regimens that might prolong time off conventional HAART whilst waiting for a new regimen that is either fully suppressive or less toxic or less demanding for the patient.

To compare development of new mutations in the reverse transcriptase gene 24 and 48 weeks after HAART discontinuation. [ Time Frame: Through 48 weeks ] [ Designated as safety issue: No ]

Proportion of patients with any adverse event. [ Time Frame: Through 48 weeks ] [ Designated as safety issue: No ]

Proportion of patients for each adverse event. [ Time Frame: Through 48 weeks ] [ Designated as safety issue: No ]

Distribution of the intensity if each adverse event (the greatest intensity for each adverse event within a patient will be considered). [ Time Frame: Through 48 weeks ] [ Designated as safety issue: No ]

Distribution of the relationship between the adverse effect and the study drug (the strongest relation with the study drug for each adverse event within each patient will be considered). [ Time Frame: Through 48 weeks ] [ Designated as safety issue: No ]

Available genotype (current or historical) showing M184V and (≥ 2 TAMs or K65R).

CD4 cell count ≥ 350 cells/mL.

Patient request HAART interruption due to any of the following:

Patient is receiving a suppressive HAART regimen but has problems with adherence,quality of life or toxicity AND there is no alternative simpler, less toxic regimen (typically patients with substantial resistance and good virological control while receiving multiple antiretrovirals).

Due to resistance, patient is receiving a non-suppressive HAART regimen but patient is not willing to change to a new, already available, more complicated optimized salvage regimen (typically 3rd or 4th line of therapy).

Patients who are not to be included in the study according to the investigator's criterion.

Contacts and Locations

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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00362687